Breast CancerNCT06510738
Prediction of Non-sentinel Lymph Node Metastatic Status of Breast Cancer Based on Pathology-MRI Images
An observational study of Breast Cancer and Artificial Intelligence, run by Yunnan Cancer Hospital.
Trial summary
The goal of this observational study is to develop an artificial intelligence model based on pathology and magnetic resonance imaging (MRI) images to predict the metastatic status of non-sentinel lymph nodes in patients with breast cancer sentinel lymph node metastasis. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Breast Cancer, Artificial Intelligence, Lymph Node Metastasis
- How many people
- 700 participants
- Where
- No sites listed yet
- Study dates
- Aug 2024to Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: The investigators plan to retrospective collect 700 patients with breast cancer and prospective collect 150 patients with breast cancer
Who may be able to join
- Patients with primary breast cancer
- Positive sentinel lymph node biopsy and axillary lymph node dissection.
- No neoadjuvant chemotherapy, radiotherapy or ablation prior to surgery.
- MRI within 3 weeks prior to surgery.
Who cannot join
- recurrent breast cancer or history of surgery or radiation therapy in the axilla
- Inflammatory breast cancer
- Bilateral breast cancer or metastatic breast cancer
- previous or current history of other malignant tumors
- Sentinel lymph node count > 5
About this study
Official title: Prediction of Non-sentinel Lymph Node Metastatic Status of Breast Cancer Based on Pathology-MRI Images and Artificial Intelligence
The goal of this observational study is to develop an artificial intelligence model based on pathology and magnetic resonance imaging (MRI) images to predict the metastatic status of non-sentinel lymph nodes in patients with breast cancer sentinel lymph node metastasis. The main questions it aims to answer are:
Can an artificial intelligence model based on MRI images of breast cancer patients predict the non-sentinel lymph node metastatic status in patients with breast cancer sentinel lymph node metastasis?
Read more
Can an artificial intelligence model based on intraoperative frozen section images of sentinel lymph nodes in breast cancer patients predict the non-sentinel lymph node metastasis status in patients with sentinel lymph node metastasis from breast cancer?
Can artificial intelligence models based on preoperative MRI and intraoperative frozen section images of sentinel lymph nodes in breast cancer patients predict the non-sentinel lymph node metastatic status in patients with sentinel lymph node metastasis from breast cancer?
Researchers will retrospectively and prospectively collect preoperative MRI and intraoperative sentinel lymph node section images from breast cancer patients.
- Medical subject headings
- Breast Neoplasms, Lymphatic Metastasis
What is being measured
The primary outcome is the main question the study is designed to answer.
Non-sentinel lymph node metastatic status
metastasis or non-metastasis
Measured: 2024-2025
Accuracy, Sensitivity, Specificity，Area under the curve
The performance of predicting non-sentinel lymph node metastatic status
Measured: 2024-2025
Positive predictive value，Negative predictive value
The performance of predicting non-sentinel lymph node metastatic status
Measured: 2024-2025
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2024
- Study startAug 2024 (estimated)
- Primary completionJun 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 700 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yunnan Cancer Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Affiliated Cancer Hospital of Shantou University Medical College
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06510738
- Sponsor's protocol ID
- KYLX2024-128
- Status last verified
- Jul 2024
- First submitted
- 14 Jul 2024
- Last updated
- 13 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prediction of Non-sentinel Lymph Node Metastatic Status of Breast Cancer Based on Pathology-MRI Images and Artificial Intelligence
- ClinicalTrials.gov ID
- NCT06510738
- Acronym / sponsor ID
- KYLX2024-128
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 700 participants (estimated)
- Lead sponsor
- Yunnan Cancer HospitalUniversity, hospital or other
- Collaborators
- Affiliated Cancer Hospital of Shantou University Medical College
- Study start
- Aug 2024 (estimated)
- Primary completion
- Jun 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 19 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this observational study is to develop an artificial intelligence model based on pathology and magnetic resonance imaging (MRI) images to predict the metastatic status of non-sentinel lymph nodes in patients with breast cancer sentinel lymph node metastasis. The main questions it aims to answer are:
Can an artificial intelligence model based on MRI images of breast cancer patients predict the non-sentinel lymph node metastatic status in patients with breast cancer sentinel lymph node metastasis?
Can an artificial intelligence model based on intraoperative frozen section images of sentinel lymph nodes in breast cancer patients predict the non-sentinel lymph node metastasis status in patients with sentinel lymph node metastasis from breast cancer?
Can artificial intelligence models based on preoperative MRI and intraoperative frozen section images of sentinel lymph nodes in breast cancer patients predict the non-sentinel lymph node metastatic status in patients with sentinel lymph node metastasis from breast cancer?
Researchers will retrospectively and prospectively collect preoperative MRI and intraoperative sentinel lymph node section images from breast cancer patients.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The investigators plan to retrospective collect 700 patients with breast cancer and prospective collect 150 patients with breast cancer
Key inclusion criteria (4 listed)
- Patients with primary breast cancer
- Positive sentinel lymph node biopsy and axillary lymph node dissection.
- No neoadjuvant chemotherapy, radiotherapy or ablation prior to surgery.
- MRI within 3 weeks prior to surgery.
Key exclusion criteria (5 listed)
- recurrent breast cancer or history of surgery or radiation therapy in the axilla
- Inflammatory breast cancer
- Bilateral breast cancer or metastatic breast cancer
- previous or current history of other malignant tumors
- Sentinel lymph node count > 5
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Non-sentinel lymph node metastatic status
Time frame: 2024-2025
metastasis or non-metastasis
Accuracy, Sensitivity, Specificity，Area under the curve
Time frame: 2024-2025
The performance of predicting non-sentinel lymph node metastatic status
Positive predictive value，Negative predictive value
Time frame: 2024-2025
The performance of predicting non-sentinel lymph node metastatic status
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer and Artificial Intelligence, run by Yunnan Cancer Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Non-sentinel lymph node metastatic status (time frame: 2024-2025). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2024.